Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia.

NCT ID: NCT05842239

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2025-12-01

Brief Summary

Infertility in a couple is defined as the inability to achieve conception despite one year of frequent, unprotected intercourse. Infertility affects approximately 12% of couples attempting to conceive. The goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.

Detailed Description

Infertility in a couple is defined as the inability to achieve conception despite one year of frequent, unprotected intercourse. Infertility affects approximately 12% of couples attempting to conceive. The male factor is equally attribute to couple infertility like woman infertility.

Male infertil¬ity may have many reasons. In up to 90% of male infertility cases, there is a decrease in sperm count or the might show poor sperm quality. During spermatogenesis, mitochondria undergo continuous morphological and distributional changes with germ cell development. Deficiencies in these processes lead to mitochondrial dysfunction and abnormal spermatogenesis, thereby causing male infertility.

In addition to mitochondria, telomer also play a significant role in sperm functionality. Telomere length is considered one of the most relevant biological markers of genomic stability. The negative impact of telomere shortening on sperm quality has been suggested as an important indicator of male infertility.

It is now understood that Hyperbaric oxygen treatment (HBOT), triggers both oxygen and pressure sensitive genes, resulting in inducing mitochondrial proliferation, increase in complex I activity and those mitochondrial efficiency. With respect to telomers, in a recent study, it was demonstrated that HBOT can induce telomeres elongation.

The goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.

All eligible participants will receive hyperbaric treatment. The treatment will be administrated in a multi-place chamber. The protocol comprises of 60 daily sessions, 5 sessions per week within a three-month period. Each session includes breathing 100% oxygen by mask at 2ATA for 90 minutes with 5-minute air breaks every 20 minutes.

The evaluation procedure will be performed 4 times, at baseline, after 40 sessions, end of the treatment period and 60 days after the treatment ended, and includes sperm analysis, sperm and lymphocyt telomeres length.

Conditions

Oligospermia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperbaric Oxygen Therapy active arm

The protocol comprises of 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period.

Group Type: EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type: DEVICE

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

Interventions

Hyperbaric oxygen therapy

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age above 21 years

2. At least two sperm examination showing oligospermia (<15·106 sperm/mL)

3. Diagnosis of idiopathic oligospermia.

4. Subject willing and able to read, understand and sign an informed consent

Exclusion Criteria

1. Inability to attend scheduled clinic visits and/or comply with the study protocol

2. Active malignancy

3. Previous treatment with chemotherapy and/or radiation therapy

4. Substance use at baseline

5. Severe or unstable physical disorders or major cognitive deficits at baseline

6. HBOT for any reason prior to study enrolment

7. Chest pathology incompatible with pressure changes (including moderate to severe asthma)

8. Ear or Sinus pathology incompatible with pressure changes

9. Chronic disease like diabetes mellitus, ischemic heart disease etc.

10. Active smoking

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shachar Finci, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf-Harofhe MC

Locations

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Ẕerifin, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shachar Finci, MD

Role: CONTACT

shacharf@shamir.gov.il

97289542395

Shai a Efrati, MD

Role: CONTACT

efratishai@outlook.com

972549212866

Facility Contacts

Shachar Finci, MD

Role: primary

shacharf@shamir.gov.il

972-8-9779393

Other Identifiers

209-22-ASF

Identifier Type: -

Identifier Source: org_study_id